Concurrent Chemotherapy and Pelvic Radiation Therapy Compared With Pelvic Radiation Therapy Alone as Adjuvant Therapy After Radical Surgery in High-Risk Early-Stage Cancer of the Cervix.

PURPOSE: To determine whether the addition of cisplatin-based chemotherapy (CT) to pelvic radiation therapy (RT) will improve the survival of early-stage, high-risk patients with cervical carcinoma. PATIENTS AND METHODS: Patients with clinical stage IA2, IB, and IIA carcinoma of the cervix, initially treated with radical hysterectomy and pelvic lymphadenectomy, and who had positive pelvic lymph nodes and/or positive margins and/or microscopic involvement of the parametrium were eligible for this study. Patients were randomized to receive RT or RT + CT. Patients in each group received 49.3 GY RT in 29 fractions to a standard pelvic field. Chemotherapy consisted of bolus cisplatin 70 mg/m2 and a 96-hour infusion of fluorouracil 1,000 mg/m2/d every 3 weeks for four cycles, with the first and second cycles given concurrent to RT. RESULTS: Between 1991 and 1996, 268 patients were entered onto the study. Two hundred forty-three patients were assessable (127 RT + CT patients and 116 RT patients). Progression-free and overall survival are significantly improved in the patients receiving CT. The hazard ratios for progression-free survival and overall survival in the RT only arm versus the RT + CT arm are 2.01 (P = .003) and 1.96 (P = .007), respectively. The projected progression-free survivals at 4 years is 63% with RT and 80% with RT + CT. The projected overall survival rate at 4 years is 71% with RT and 81% with RT + CT. Grades 3 and 4 hematologic and gastrointestinal toxicity were more frequent in the RT + CT group. CONCLUSION: The addition of concurrent cisplatin-based CT to RT significantly improves progression-free and overall survival for high-risk, early-stage patients who undergo radical hysterectomy and pelvic lymphadenectomy for carcinoma of the cervix.

Surgical outcomes in gynecologic oncology in the era of robotics: analysis of first 1000 cases.

OBJECTIVE: We sought to examine outcomes in an expanding robotic surgery (RS) program. STUDY DESIGN: In all, 1000 women underwent RS from May 2006 through December 2009. We analyzed patient characteristics and outcomes. A total of 377 women undergoing RS for endometrial cancer staging (ECS) were compared with the historical data of 131 undergoing open ECS. RESULTS: For the entire RS cohort of 1000, the conversion rate was 2.9%. Body mass index increased over 3 time intervals: T1 = 26.2, T2 = 29.5, T3 = 30.1 (T1:T2, P = .01; T1:T3, P = .0001; T2:T3, P = .037). Increasing body mass index was not associated with increased major complications: T1 = 8.7%, T2 = 4.3%, T3 = 5.7%. In the ECS cohort, as compared with open ECS, women undergoing RS had lower blood loss (46.9 vs 197.6 mL, P < .0001), shorter hospitalization (1.4 vs 5.3 days, P < .0001), fewer major complications (6.4% vs 20.6%, P < .0001), with higher lymph node counts (15.5 vs 13.1, P = .007). CONCLUSION: RS is associated with favorable morbidity and conversion rates in an unselected cohort. Compared to laparotomy, robotic ECS results in improved outcomes.

FOXP3+ regulatory T-cells are abundant in vulvar Paget's disease and are associated with recurrence.

OBJECTIVE: To characterize clinical features of vulvar Paget's disease, and examine the quantity of immunosuppressive regulatory T-cells in vulvar Paget's tissue. METHODS: Vulvar Paget's cases from 1992 to 2007 from two institutions were identified by pathology database search. Regulatory T-cells were identified with FOXP3 immunohistochemistry and quantified at the dermal-epidermal junction using image analysis software. Thirteen non-neoplastic inflammatory cases were stained for comparison. RESULTS: Cases included 33 women treated for primary vulvar Paget's, and 7 referred at recurrence. Of the 24 primary cases with greater than 5 months follow-up, recurrence was documented in 12/24(50%). Eight women (20%) recurred multiple times, but no recurrences were invasive. Significantly more patients with positive margins developed recurrent disease (82% vs 23%, p=0.01). Secondary neoplasms occurred in 10/40(25%). FOXP3+ cells at the dermal-epidermal junction were quantified in 29 primary and 13 recurrent tissue samples. FOXP3+ cells were absent in surrounding normal vulvar skin. FOXP3+ cells averaged 66/HPF in primary vulvar Paget's and 66/HPF in recurrent Paget's, compared to 22/HPF in non-neoplastic inflammatory cases (p=0.0003, p=0.001). Primary cases with positive surgical margins had more FOXP3+ cells than those with negative margins (85 vs 49, p=0.01). Recurrent cases with positive margins had more FOXP3+ cells than negative cases (84 vs 33, p=0.06). FOXP3 levels in primary specimens were higher in cases which recurred (78 vs 35, p=0.02). CONCLUSIONS: Increased regulatory T-cells may be associated with more extensive cases of vulvar Paget's disease that result in positive surgical margins and are associated with recurrence of disease, suggesting immunosuppression as a key factor.

Prognostic relevance of carbonic anhydrase-IX in high-risk, early-stage cervical cancer: a Gynecologic Oncology Group study.

OBJECTIVES: This study aimed to determine whether carbonic anhydrase-IX (CA-IX) was associated with progression-free survival (PFS) and overall survival (OS) in women with high-risk, early-stage cervical cancer treated with adjuvant pelvic radiotherapy with or without radiosensitizing chemotherapy. METHODS: CA-IX expression was detected using an immunohistochemistry assay and categorized as low when 80% tumor cells display CA-IX staining. Associations between CA-IX expression and clinical characteristics, angiogenesis marker expression, and clinical outcome were evaluated. RESULTS: High CA-IX expression was observed in 35/166 (21.1%) of cases. CA-IX expression was not associated with age, race, stage, cell type, grade, positive margins, parametrial extensions, positive lymph nodes, or lymphovascular space invasion but was associated with tumor size categorized as <2 , 2-2.9 , or >or=3 cm (high expression: 4.7% vs. 23.2% vs. 32.5%, P=0.003) and cervical invasion confined to the inner two-thirds compared with the outer third of the cervix (high expression: 6.1% vs. 23.7%, P=0.028). CA-IX expression was not associated with immunohistochemical expression of p53, CD31, CD105, thrombospondin-1, or vascular endothelial growth factor-A. Women with high versus low CA-IX expression had similar PFS (P=0.053) and significantly worse OS (P=0.044). After adjusting for prognostic clinical covariates, high CA-IX expression was an independent prognostic factor for PFS (hazard ratio [HR]=2.12; 95% confidence interval [CI]=1.13-3.95; P=0.019) and OS (HR=2.41; 95% CI=1.24-4.68; P=0.009). CONCLUSIONS: Tumor hypoxia measured by immunohistochemical expression of CA-IX is an independent prognostic factor for both PFS and OS in high-risk, early-stage cervical cancer.

Factors affecting risk of mortality in women with vaginal cancer.

OBJECTIVE: To estimate the current effect of demographics, pathology, and treatment on mortality among women with vaginal cancer. METHODS: Using data from 17 population-based cancer registries that participate in the Surveillance, Epidemiology, and End Results program, 2,149 women diagnosed with primary vaginal cancer between 1990 and 2004 were identified. The association between various demographic factors, tumor characteristics, and treatments and risk of vaginal cancer mortality were evaluated using Cox proportional hazards modeling. RESULTS: The mean age+/-standard deviation at diagnosis was 65.7+/-14.3 years. Approximately 66% of all cases were non-Hispanic whites. Incidence was highest among African-American women (1.24 per 100,000 person-years). The 5-year disease-specific survival was 84% (stage I), 75% (stage II), and 57% (stage III/IV). In a multivariate adjusted model, women with tumors greater than 4 cm and advanced disease had elevated risks of mortality (hazard ratios 1.71 and 4.67, respectively). Compared with women with squamous cell carcinomas, patients with vaginal melanoma had a 1.51-fold (95% confidence interval 1.07-2.41) increased risk of mortality. Surgery alone as a treatment modality had the lowest risk of mortality. The risk of mortality has decreased over time, as women diagnosed after 2000 had an adjusted 17% decrease in their risk of death compared with women from 1990-1994. CONCLUSION: Stage, tumor size, histology, and treatment modality significantly affect a woman's risk of mortality from vaginal cancer. There seems to be a survival advantage that is temporally related to the advent of chemoradiation.

Markers of angiogenesis in high-risk, early-stage cervical cancer: A Gynecologic Oncology Group study.

OBJECTIVES: To determine whether markers of tumor angiogenesis were associated with progression-free survival (PFS) and overall survival (OS) in women with high-risk, early-stage cervical cancer treated on a phase III trial. METHODS: One hundred seventy-three tumor specimens were analyzed by semi-quantitative immunohistochemical (IHC) staining for vascular endothelial growth factor (VEGF, pro-angiogenesis factor), thrombospondin-1 (TSP-1, anti-angiogenesis factor), CD31 (non-specific endothelial marker), and CD105 (tumor-specific endothelial marker). Tumoral histoscores (HS) were calculated for VEGF using the formula: [% cells positivex(intensity+1)]. TSP-1 specimens were categorized as negative or positive. CD31 and CD105 microvessel density (MVD) "hotspots" were counted in three 20x high-power fields. Associations between angiogenesis markers and survival were evaluated. RESULTS: TSP-1 expression was observed in 65% of cases while 66% expressed high VEGF (>or=200), 34% exhibited high CD31 (CD31>or=110) and 66% displayed high CD105 (CD105>or=28). In univariate analyses CD31 MVD, but not tumor TSP-1, was associated with improved PFS (HR=0.37; 95% CI=0.18-0.76; p=0.007) and OS (HR=0.37; 95% CI=0.17-0.79; p=0.010). After adjusting for prognostic clinical covariates, high CD31 MVD, but not TSP-1, VEGF or CD105 MVD, was an independent prognostic factor for PFS (HR=0.36; 95% CI=0.17-0.75; p=0.006) and OS (HR=0.36; 95% CI=0.17-0.79; p=0.010). CONCLUSIONS: Tumor angiogenesis measured by CD31 MVD is an independent prognostic factor for both PFS and OS in high-risk, early-stage cervical cancer. We hypothesize that this finding may be explained by improved treatment response in well-vascularized, well-oxygenated tumors.

Robotic surgery in gynecologic oncology: program initiation and outcomes after the first year with comparison with laparotomy for endometrial cancer staging.

OBJECTIVE: The objective of the study was to evaluate outcomes during the first year of a robotic surgery program in gynecologic oncology. STUDY DESIGN: We studied the initiation of a robotic surgery program with prospective data collection, including intraoperative times, estimated blood loss (EBL), length of stay (LOS), lymph node yields, and complications. Patients were compared with historical and contemporary open staging surgery for endometrial cancer. RESULTS: One hundred eighteen patients underwent robotic surgery (mean age 52.5 years, body mass index of 26.3 kg/m(2), hospital stay of 32.4 hours), with 8 major and 13 minor complications. Compared with open endometrial staging (n = 131), the robotic procedure (n = 25) was longer (283 vs 139 minutes, P < .0001), had less blood loss (66.6 vs 197.6 mL, P < .0001), and had shorter length of stay (40.3 vs 127 hours, P < .0001) with comparable node yields (17.5 vs 13.1, P = .1109). CONCLUSION: Robotic surgery is feasible in gynecologic oncology and facilitated a dramatic expansion in our minimally invasive surgical practice. Despite longer operative times, EBL and LOS are reduced and lymph node yields are comparable.

Clear cell adenocarcinoma of the vagina in a patient with vaginal endometriosis.

BACKGROUND: Malignant transformation of endometriosis is an infrequent complication of endometriosis. Extragonadal disease is uncommon. CASE: 55-year-old female presented with postmenopausal bleeding. Physical examination revealed a 2-cm polypoid lesion at the posterior vaginal apex, which was found to be a moderately differentiated invasive adenocarcinoma. Final pathology at the time of definitive surgery demonstrated a clear cell adenocarcinoma of the vagina arising in vaginal endometriosis. CONCLUSION: Vaginal endometriosis may lead to the development of cancer. Malignancy arising in endometriotic foci is rare, but most commonly occurs in the ovary. We report a case of clear cell malignancy arising in vaginal endometriosis, adding to only seven cases previously reported. Risk factors include unopposed estrogen and obesity, but it may occur in the absence of either.

Effects of temperature and soil components on emissions from pyrolysis of pyrene-contaminated soil.

Effects of temperature and soil on yields and identities of light gases (H2, CH4, C2H2, C2H4, C2H6, CO, and CO2) and polycyclic aromatic hydrocarbons (PAH) from thermal treatment of a pyrene-contaminated (5 wt%) soil in the absence of oxygen were determined for a U.S. EPA synthetic soil matrix prepared to proxy U.S. Superfund soils. Shallow piles (140-170 mg) of contaminated soil particles and as controls, neat (non-contaminated) soil (140-160 mg), neat pyrene (10-15 mg), neat sand (230 mg), and pyrene-contaminated sand (160 mg), were heated in a ceramic boat inside a 1.65 cm i.d. pyrex tube at temperatures from 500 to 1100 degrees C under an axial flow of helium. Volatile products spent 0.2-0.4s at temperature before cooling. Light gases, PAH and a dichloromethane extract of the residue in the ceramic boat, were analyzed by gas chromatography or high pressure liquid chromatography (HPLC). Over 99% pyrene removal was observed when heating for a few tens of seconds in all investigated cases, i.e., at 500, 650, 750, 1000, and 1100 degrees C for soil, and 750 and 1000 degrees C for sand. However, each of these experiments gave significant yields (0.2-16 wt% of the initial pyrene) of other PAH, e.g., cyclopenta[cd]pyrene (CPP), which mutates bacterial cells and human cells in vitro. Heating pyrene-polluted soil gave pyrene conversions and yields of acetylene, CPP, and other PAH exceeding those predicted from similar, but separate heating of neat soil and neat pyrene. Up to 750 degrees C, recovered pyrene, other PAH, and light gases accounted for all or most of the initial pyrene whereas at 1000 and 1100 degrees C conversion to soot was significant. A kinetic analysis disentangled effects of soil-pyrene interactions and vapor phase pyrolysis of pyrene. Increase of residence time was found to be the main reason for the enhanced conversion of pyrene in the case of the presence of a solid soil or sand matrix. Light gas species released due to the thermal treatment, such as acetylene and methane, lead the formation of other, pyrene-derived PAH, e.g., methylpyrenes, cyclopenta[cd]pyrene, and benzo[a]pyrene. Implications of these findings for the chemistry of soil thermal decontamination and for diagnosing potential defects in soil thermal cleaning, e.g., incomplete elimination of targeted pollutants and formation of adverse by-products, are discussed.

Rethinking the use of radiation and chemotherapy after radical hysterectomy: a clinical-pathologic analysis of a Gynecologic Oncology Group/Southwest Oncology Group/Radiation Therapy Oncology Group trial.

OBJECTIVE: To retrospectively analyze data from a previously reported randomized trial of either pelvic radiation (RT) or RT + chemotherapy (CT) in patients undergoing radical hysterectomy and pelvic lymphadenectomy with positive pelvic lymph nodes, parametrial involvement, or surgical margins; to explore associations between RT + CT; and to investigate histopathologic and clinical factors which might be predictive of recurrence. METHODS: Histopathologic sections from biopsies and hysterectomies and clinical data were reviewed from patients with stage IA2, IB, or IIA cervical cancer treated with RT or RT + CT (cisplatin 70 mg/m2 plus fluorouracil 1000 mg/m2 every 3 weeks for four cycles). A univariate analysis was performed because the relatively small sample size limited the interpretation of a multivariate analysis. RESULTS: Of the 268 enrolled women, 243 (RT = 116; RT + CT = 127) were evaluable. The beneficial effect of adjuvant CT was not strongly associated with patient age, histological type, or tumor grade. The prognostic significance of histological type, tumor size, number of positive nodes, and parametrial extension in the RT group was less apparent when CT was added. The absolute improvement in 5-year survival for adjuvant CT in patients with tumors < or =2 cm was only 5% (77% versus 82%), while for those with tumors >2 cm it was 19% (58% versus 77%). Similarly, the absolute 5-year survival benefit was less evident among patients with one nodal metastasis (79% versus 83%) than when at least two nodes were positive (55% versus 75%). CONCLUSIONS: In this exploratory, hypothesis-generating analysis, adding CT to RT after radical hysterectomy, appears to provide a smaller absolute benefit when only one node is positive or when the tumor size is < 2 cm. Further study of the role of CT after radical hysterectomy in patients with a low risk of recurrence may be warranted.

Phase II study of CT-2103 in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.

PURPOSE: To evaluate the safety and efficacy of CT-2103, a novel conjugate of paclitaxel and poly-L-glutamic acid, in heavily pretreated patients with recurrent ovarian, fallopian tube, or peritoneal cancer. PATIENTS AND METHODS: Ninety-nine patients with measurable disease received intravenous CT-2103 at 175 mg/m2 of conjugated paclitaxel over 10 minutes every 3 weeks without routine premedications. Platinum-sensitive (n = 42) and platinum-refractory or platinum-resistant patients (n = 57) were enrolled. Thirty-nine patients (39%) had received one or two prior regimens, and 60 patients (61%) had received between three and 12 regimens. RESULTS: In 99 patients, the median number of cycles was three (range, one to 14 cycles). The response rate (RR) for all patients was 10% (10 of 99 patients), with median time to disease progression (TTP) of 2 months. The RR (partial response) in platinum-sensitive and platinum-resistant patients was 14% (six of 42 patients) and 7% (four of 57 patients), respectively. In patients with only one or two prior regimens, the RR in platinum-sensitive and platinum-resistant patients was 28% (five of 18 patients) and 10% (two of 21 patients), with a median TTP of 4 and 2 months, respectively. Grade 2 (15 patients) or 3 (15 patients) neuropathy was reported in 30 patients (30%). Grade 2 hypersensitivity occurred in eight patients (8%) who were subsequently treated with premedications; one patient had grade 3 hypersensitivity and was removed. Grade 2 alopecia was absent. CONCLUSION: CT-2103 is active in patients with recurrent ovarian cancer. Neurotoxicity in these heavily pretreated patients was more frequent than predicted from phase I trials. Further study to define toxicity and efficacy in patients with less prior therapy is ongoing.

Estimating the impact of new clinical trial proven cancer therapy and cancer chemoprevention on population mortality: the Karnofsky Memorial lecture.

PURPOSE: The 31-year "war on cancer" has focused largely on therapeutic (as opposed to preventative) cancer research, which, in both the public and private sector, has received the majority of funding. Meanwhile the prevention of cancer has received less attention. PATIENTS AND METHODS: We analyzed eight positive phase III therapeutic trials of the Southwest Oncology Group, and estimated how the observed improvements in survival from the new therapies would impact mortality at the population level (utilizing Surveillance, Epidemiology, and End Results-data). We compared these results with the impact of the Prostate Cancer Prevention Trial. The measure of impact was person-years saved in the first 5 years. RESULTS: Estimates of person-years saved in the first 5 years included 28,534 from improved treatment of localized bladder cancer and 26,241 from improved treatment of advanced lung cancer, representing, respectively, 31.4% and 2.8% of the person-years which could have been saved for these diseases (the "relative impact of new treatment on survival"). The new therapies from all eight positive phase III trials would have saved 114,641 person-years over the first 5 years. The estimate from the Prostate Cancer Prevention Trial was 99,441 person-years over the first 5 years. CONCLUSION: New cancer therapies have a proven and quantifiable impact on population mortality. Successful cancer prevention has a similarly large impact. However, federal funding for cancer prevention is less than half that of cancer treatment. As a result of its enormous potential for extending life, cancer prevention warrants increased funding and support from federal funding agencies.

Adequate staging for uterine cancer can be performed through Pfannenstiel incisions.

OBJECTIVE: To determine if the type of operative incision influences the adequacy of surgical staging in patients with uterine cancer. METHODS: All patients with uterine cancer referred to the Swedish Medical Center Cancer Institute for adjuvant radiotherapy between June 1, 1989, and June 1, 1999, who underwent comprehensive surgical staging and for whom complete records could be obtained were eligible. Data on type of incision, weight, medical comorbidities, histology, total number and distribution of lymph nodes (LN), estimated blood loss, complications, and length of stay were abstracted retrospectively. Statistical analysis with two-tailed Student t test, chi(2), Fisher's exact, and Kaplan-Meier survival curves were performed. RESULTS: Five hundred four women with uterine cancers were referred to the Cancer Institute with 332 meeting inclusion criteria. A vertical midline incision (ML) was used in 236 (72%) while 96 (28%) received a Pfannenstiel incision (PI). No panniculectomies were performed. There were no statistically significant differences in age, weight, stage, histology, comorbidities, or estimated blood loss between the ML and PI groups. ML was associated with significantly more intraoperative and postoperative complications (34 vs. 7; P = 0.003). When compared to ML a greater number of total LN (21.0 vs. 16.8; P = 0.001) and a comparable number of pelvic LN (13.7 vs. 12.2; P = 0.14) were procured through a PI. More patients with a ML (72% vs. 63%; P = 0.13) had para-aortic lymph nodes (PALN) dissected; however, when obtained equivalent numbers of nodes were removed (3.52 vs. 4.36; P = 0.14). Overall, the median length of stay was statistically shorter for those patients operated on via a PI (4 vs. 3 days; P = 0.007). The projected 5-year disease-free (83% vs. 85%) and disease-specific (87% vs. 85%) survival was unaffected by incision. In the heaviest quartile of patients (>180 lb), a statistically greater number of total LN (23.3 vs. 16.5; P = 0.005) and pelvic LN (16.7 vs. 11.5; P = 0.05) were obtained with a PI. Again, PALN were sampled more frequently (67% vs. 56%; P = 0.45) in patients with a ML, but the mean LN yield was no different (3.91 vs. 5.20; P = 0.37). Likewise, in this heaviest quartile, there were no statically significant differences in operative complications (7 vs. 1; P = 0.43) with either incision. CONCLUSIONS: Comprehensive surgical staging for uterine cancers can be adequately performed through a PI without greater morbidity or mortality. By using this surgical approach, patients with uterine cancer can benefit from the inherent benefits previously described for PI. Appropriate patient selection, however, is necessary.

Three-consecutive-day topotecan is an active regimen for recurrent epithelial ovarian cancer.

OBJECTIVE: The aim was to determine the response rate and toxicity of topotecan administered Days 1-3 every 21 days for recurrent epithelial cancers of the ovary, peritoneum, or fallopian tube. A 3-day regimen may be more convenient and less expensive than a 5-day schedule. METHODS: Patients with recurrent epithelial cancer of the ovary, peritoneum, or fallopian tube who had adequate hepatic, renal, and hematologic function were eligible for participation. Topotecan (2 mg/m(2)) was administered for 3 consecutive days every 21 days. Response was measured clinically and serologically. Granulocyte colony stimulating factors (GCSF) were not utilized prophylactically, but could be added under specific conditions. RESULTS: Thirty-one patients with recurrent ovarian cancer whose median age was 63 (range 32-84) received 165 cycles of topotecan (median = 6; range 2-8) and are evaluable for toxicity. The median number of prior regimens was 1. Topotecan was administered on schedule in 96.6% of cycles. Grade 3/4 neutropenia was seen in 29.1 and 23.6% of courses, respectively; but only 3.4% of cycles required GCSF support (6 cycles for 2 patients). Grade 4 thrombocytopenia was rare (1% of cycles). Nonhematologic toxicity was mild. The response rate for 28 evaluable patients was 32.1% (10.7% complete response (CR) and 21.4% partial response (PR)); stable disease was seen in 17.9% of patients. The median progression-free interval (PFI) for all patients was 15.5 weeks (range 5-40). Eighteen platinum-sensitive patients demonstrated a 43.4% response rate (12.5% CR and 31.3% PR); stable disease was documented in 18.8%. The median PFI for platinum-sensitive patients was 18.5 weeks (range 5-40). CONCLUSION: Topotecan is an effective regimen with acceptable toxicity for recurrent ovarian cancer when administered for 3 consecutive days (2 mg/m(2)) every 21 days. It can be delivered on schedule without GCSF support in the vast majority of patients.

Adjuvant high dose rate vaginal brachytherapy as treatment of stage I and II endometrial carcinoma.

OBJECTIVE: To evaluate the efficacy of high dose rate vaginal brachytherapy in the treatment of International Federation of Gynecology and Obstetrics stage IB, IC, and II endometrial carcinoma after surgical staging and complete lymphadenectomy. METHODS: All patients with stage IB, IC, or II adenocarcinoma or adenosquamous carcinoma of the endometrium who received postoperative high dose rate vaginal brachytherapy at our institution between June 1, 1989, and June 1, 1999, were eligible. High dose rate vaginal brachytherapy was delivered in three fractions of 700 cGy. Retrospective chart review was performed. Kaplan-Meier estimates were calculated for disease-free and overall survival. RESULTS: One hundred sixty-four women were identified. Fifty-six percent had stage IB disease, 30% had stage IC disease, and 14% had stage II disease. Approximately one third of patients had high-grade lesions and nearly 40% had deep myometrial invasion. Median follow-up was 65 months (range 6-142 months). To date, 14 patients have had recurrence; 2 at the vaginal apex, 9 at distant sites, 1 at the pelvic sidewall, 1 simultaneously in the pelvis and at a distant site, and 1 at an unknown site. Both patients with vaginal apex recurrences had salvage therapy and are now free of disease. The overall 5-year survival and disease-free survival rates were 87% and 90%, respectively. There were no Radiation Therapy Oncology Group grade 3 or 4 toxicities. High dose rate vaginal brachytherapy was approximately $1,000 less expensive than external-beam whole-pelvic radiation. CONCLUSIONS: Adjuvant high dose rate vaginal brachytherapy in thoroughly staged patients with intermediate-risk endometrial carcinoma provides excellent overall and disease-free survival with less toxicity and at less cost compared with whole-pelvic radiation.